Design controls are certainly enforced throughout the development process of medical devices in the EU, the real question is whether or not they are sufficient enough to yield safe and effective medical devices to market. Design controls fall under the device history file (DHF) when developing a medical device in the US, but the same does not go for the technical file of a EU medical device. The main difference between the DHF and the technical file is that the technical file is less regulated in terms of having a medical device conform to meet the essential requirements. This “conformity assessment” of EU devices are what allows the manufacturers to decide their safety/efficacy standards by allowing their devices to be conducted by an independent commercial organization rather than a regulatory agency.

A technical file is said to be identical to a 510(k) in the sense that it aims to prove that a device meets the standards of a medical device’s regulations, but unlike a 510(k) it does not require a clinical evaluation report. This means that an EU Class I or IIa/b medical device does not have to include its clinical investigation, risk, or post-market surveillance. As a result, medical devices in the EU are being brought to market at a quicker pace than in the US, which for example, can be represented by a 1-3 year delay in the development of drug-eluting stents in the US compared to the EU. Low to medium-risk devices such as Class I and II EU devices are brought to conformity by what’s called a “literature route”, which only requires bench-testing, animal testing, and pre-existing clinical data from published studies in order for the device to enter the market. Furthermore, high-risk devices that do require clinical data undergo a more expedited form of clinical testing. US clinical testing for Class III devices includes a randomized trial of hundreds of patients while EU trials consist of non-randomized (single arm) trials of a maximum 100 patients. Simply put, the philosophies between the EU and the US can be stated as the EU seems to produce more medical devices than the US, but the US puts more thought and care into their devices before releasing them to market. Some might say that the EU focuses on the quantity of medical devices developed while the US prioritizes quality.

Is it possible that the US puts too much concern and scrutiny into medical devices attempting to enter market? Is there a significant difference between medical device recalls in the EU vs. the US? Assuming the EU and the US have a similar track record of medical device recalls, does that imply that the design control standards should change for either side or remain the same? Why or why not?

Reference:
(1) “Medical Device Development: US and EU Differences” (2006) Applied Clinical Trials
(2) Speer, John, “Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?” (Nov. 2017) Medical Device and Diagnostic Industry